Low-Protein Diet with Low-Protein Foods Versus a LPD Without LP Foods in Patients with Chronic Kidney Disease (CKD)

January 27, 2025 updated by: Dr. Schär AG / SPA

Randomized Controlled Trial of a Low-Protein Diet (LPD) with Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients with Chronic Kidney Disease (CKD): Efficacy and Feasibility Study

The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Abbeville, France, 80100
        • Recruiting
        • Clinique sainte isabelle
        • Contact:
        • Contact:
          • Morgane Wetzstein
      • Aix-en-Provence, France
        • Completed
        • Cabinet médical du Dr Magnant
      • Besançon, France
        • Recruiting
        • CHU Besançon
        • Contact:
          • Cecile Courivaud, Dr
        • Contact:
        • Contact:
          • Didier Duclous, Dr
        • Contact:
          • Jamal Bamould, Dr
        • Contact:
          • Thomas Crepin, Dr
        • Contact:
          • Caroline Roubiou, Dr
        • Contact:
          • Maria Yannaraki, Dr
        • Contact:
          • Melchior Chabannes, Dr
        • Contact:
          • Jean Siebel, Dr
        • Contact:
          • Mathilde Colladant, Dr
      • Bordeaux, France
        • Recruiting
        • Polyclinique Bordeaux Nord Aquitaine
        • Contact:
        • Contact:
          • Manon Charrier, Dr
        • Contact:
          • Ismail Amal, Dr
        • Contact:
          • Arthur Lacapere, Dr
      • Bordeaux, France
        • Recruiting
        • Maison du Rein
        • Contact:
        • Contact:
          • Mathilde prezelin-reydit, Dr
        • Contact:
          • Catherine Lasseur, Dr
        • Contact:
          • Charlotte Dumas de la roque, Dr
        • Contact:
          • Celine Nodimar, Dr
        • Contact:
          • Ludovic Aubin, Dr
        • Contact:
          • Jackaria Muhammad, Dr
      • Chalon-sur-Saône, France
        • Recruiting
        • CH Chalon
        • Contact:
        • Contact:
          • Ayman Abokasem, Pr
        • Contact:
          • Abdelkader Bemrah, Dr
        • Contact:
          • Philippe Dubot, Dr
        • Contact:
          • Quentin Bernard, Dr
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Gabriel Montpied
        • Contact:
          • Anne-Elisabeth Heng, Pr
        • Contact:
        • Contact:
          • Alba Atenza, Dr
        • Contact:
          • Cyril Garrouste, Dr
        • Contact:
          • Clarisse Greze, Dr
        • Contact:
          • Carole Philipponnet, Dr
        • Contact:
          • Charlotte Uro-Coste, Dr
      • Dijon, France
        • Withdrawn
        • Santélys BFC
      • Le Mans, France
        • Recruiting
        • CH Le mans
        • Contact:
          • Giorgina Piccoli, Pr
        • Contact:
        • Contact:
          • Antioco Fois, Dr
        • Contact:
          • Giulia Santagati, Dr
      • Lyon, France
        • Recruiting
        • Hospices Civiles de Lyon
        • Contact:
        • Contact:
          • Laetitia Koppe, Pr
        • Contact:
          • Denis Fouque, Dr
        • Contact:
          • Etienne Novel Catin, Dr
        • Contact:
          • Christophe Barba, Dr
        • Contact:
          • Solenne Pelletier, Dr
        • Contact:
          • Pascaline Alix, Dr
        • Contact:
          • Mezaache, Sarah
      • Lyon, France
        • Withdrawn
        • Hopital Edouard Heriot
      • Lyon, France
        • Recruiting
        • Saint Joseph Saint Luc
        • Contact:
        • Contact:
          • Amelie Belloi, Dr
        • Contact:
          • Emmanuel Villar, Dr
        • Contact:
          • Cecile Chauvet, Dr
        • Contact:
          • Gaelle Wehrlen, Dr
      • Marseille, France
        • Recruiting
        • Hôpital la Conception
        • Contact:
          • Stephane Burtey, Pr
        • Contact:
        • Contact:
          • Romain Vial, Dr
        • Contact:
          • Marion Sallee, Dr
      • Mâcon, France
        • Recruiting
        • CH Mâcon
        • Contact:
          • Allyriane Chartier-Dantec, Dr
        • Contact:
      • Paris, France
        • Not yet recruiting
        • APHP - Hopital Necker
        • Contact:
        • Contact:
          • Elsa Ferriere, Dr
      • Paris, France
        • Withdrawn
        • Aura Paris
      • Paris, France
        • Terminated
        • Tenon hospital -APHP
      • Romans sur Isère, France
        • Recruiting
        • Hôpital Drôme Nord
        • Contact:
        • Contact:
          • Mohamad Al Adib, Dr
      • Strasbourg, France
        • Not yet recruiting
        • Nouvel Hopital Civil
        • Contact:
        • Contact:
          • Nans Florens, Pr
        • Contact:
          • Laura Braun, Dr
        • Contact:
          • Jonas Martzloff, Dr
        • Contact:
          • Dorothée Bazin-Kara, Dr
      • Vienne, France
        • Recruiting
        • CALYDIAL
        • Contact:
        • Contact:
          • Abdallah Guerraoui, Dr
        • Contact:
          • Anna Filancia, Dr
      • Villefranche-sur-Saône, France
        • Recruiting
        • Hôpital Nord-Ouest
        • Contact:
          • Cecile Teuma, Dr
        • Contact:
          • Cécile Teuma, Dr
          • Phone Number: +33 0474096855
          • Email: CTeuma@hno.fr
        • Contact:
          • Antonin Bouchet, Dr
        • Contact:
          • Kevin Goret-Roycourt, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CKD patient stage 3a-5 (<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
  • With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
  • Above 1g protein/ kg bw (ideal body weight),
  • LPD-naïve patient,
  • Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
  • Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
  • Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
  • Having given their informed written consent regarding its participation to the protocol.

Exclusion Criteria:

  • Patient for whom dialysis or transplantation is planned/expected within the next 12 months
  • Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
  • Uncontrolled Diabetes (HbA1C >8.5%),
  • Active cancer (including a 5 years remission period),
  • Psychiatric disorders or inability to follow the protocol,
  • Evidence of any active infectious or uncontrolled inflammatory diseases,
  • Inability to provide blood samples (poor venous capital),
  • Inability to perform correct 24-hours urine collection,
  • Any change of the chronic medication within 1 month before screening,
  • Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
  • Patient with an active implanted medical device
  • Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
  • Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: COMPARATOR
Follow-up of the CKD patient according to current practice i.e. low protein diet.
Experimental: FLAVIS
Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS).
Other: Consumption of FLAVIS
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)
Time Frame: 12 month
Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein intake during the 12 months follow-up
Time Frame: 1 month, 3 month, 6 month and 9 month
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
1 month, 3 month, 6 month and 9 month
Dietary adherence
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
3-day dietary record correlated to a 24-hour urine collection
baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study
Time Frame: monthly up to 12 months
quantities consumed of FLAVIS products.
monthly up to 12 months
Effects of the LPD on weight
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Weight in kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Water in litres
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Muscles in Kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: body protein content
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Body protein content in Kg
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood
Time Frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Blood Chemistry
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine
Time Frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Urine Chemistry
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Patient quality of life
Time Frame: baseline, 3 month, 6 month and 12 month
SF-36 questionnaire score which from 0 to 100
baseline, 3 month, 6 month and 12 month
Effects of the LPD on BMI
Time Frame: baseline, 1 month, 3 month, 6 month and 12 month
Weight and height will be combined to report BMI in kg/m^2.
baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on diabetic patient glycemic profile
Time Frame: Baseline, 6 month and 12 month
Hb1Ac will be measured
Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time Frame: 1 month, 3 month, 6 month, 9 month and 12 month
Questioning and a clinical examination, biological analyses review
1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time Frame: 3 month, 6 month and 12 month
4-points Likert scale
3 month, 6 month and 12 month
Patient satisfaction with LPD
Time Frame: 3 month, 6 month and 12 month
Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
3 month, 6 month and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Schär AG / SPA

Collaborators

Slb Pharma

Investigators

  • Study Director: Laetitia Koppe, Dr, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2022

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFLAVIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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